ASPIRIN 500 mg TABLETS

Introduction

Package Leaflet: Information for the User

Aspirin 500 mg Tablets

Acetylsalicylic Acid

Package Leaflet Contents

1. What is Aspirin and what is it used for
2. What you need to know before taking Aspirin
3. How to take Aspirin
4. Possible side effects
5. Storage of Aspirin
6. Package Contents and Additional Information

1. What is Aspirin and what is it used for

The active ingredient of this medication, acetylsalicylic acid, belongs to a group of medications known as non-steroidal anti-inflammatory drugs (NSAIDs). It relieves pain and reduces fever.

This medication is used for the symptomatic relief of occasional mild or moderate pain, such as headaches, dental pain, menstrual pain, muscle pain (cramps) or back pain (lumbago), and febrile conditions in adults and adolescents over 16 years of age.

You should consult a doctor if your symptoms worsen or do not improve after 5 days for pain or 3 days for fever.

2. What you need to know before taking Aspirin

Do not take Aspirin if

• you are allergic or have had an allergic reaction to acetylsalicylic acid or any other component of this medication (listed in section 6),
• you have stomach ulcers, intestinal ulcers, or recurring gastric discomfort,
• you have had allergic reactions of an asthmatic type (difficulty breathing, shortness of breath, bronchospasm, and in some cases coughing or wheezing when breathing) when taking anti-inflammatory medications, acetylsalicylic acid, other analgesics, as well as the tartrazine dye,
• you have asthma,
• you have nasal polyps associated with asthma that are produced or increased by acetylsalicylic acid,
• you have hemophilia or other blood coagulation problems,
• you are being treated with oral anticoagulant medications,
• you have kidney and/or liver disease (renal and/or hepatic insufficiency),
• you are under 16 years of age, as the use of acetylsalicylic acid has been linked to Reye's Syndrome, a rare but serious disease,
• you are in your third trimester of pregnancy.

Be cautious with Aspirin

You should consult your doctor if you require this medication:

• if you have high blood pressure, or have reduced kidney, heart, or liver function, or have blood coagulation disorders,
• if you have had stomach ulcers or intestinal ulcers,
• if you are being treated with anticoagulants, you should consult your doctor before taking this medication,
• if you are taking anti-inflammatory medications or other types of medications, as certain medications can interact with Aspirin 500 mg tablets and produce undesirable effects (see "Use of other medications"),
• if you are allergic to other anti-inflammatory or antirheumatic medications,
• if you have a glucose-6-phosphate dehydrogenase deficiency,
• if you have had rhinitis or urticaria,

• if you have recently undergone or are scheduled to undergo surgery in the next 7 days, including dental surgery,
• if you are in your first or second trimester of pregnancy,
• do not systematically administer to prevent possible discomfort caused by vaccinations.

Other medications and Aspirin

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription, homeopathic remedies, herbal medicines, and other health-related products, as it may be necessary to interrupt treatment or adjust the dose of one of them.

This is especially important in the case of:

• other analgesics or non-steroidal anti-inflammatory medications (medications used to treat pain and/or muscle inflammation),
• certain antidepressants, such as selective serotonin reuptake inhibitors, as they increase the risk of bleeding,
• anticoagulants (medications used to "thin" the blood and prevent clot formation) such as warfarin,
• oral antidiabetics (medications to lower blood sugar levels),
• barbiturates (medications used to treat seizures),
• beta-blockers (medications for hypertension control),
• cimetidine and ranitidine (used for stomach acidity),
• medications used to prevent transplant rejection (cyclosporine and tacrolimus),
• corticosteroids, as they may increase the risk of gastrointestinal bleeding,
• digoxin (medication for the heart),
• high blood pressure (diuretics and ACE inhibitors),
• phenytoin and valproic acid (antiepileptics),
• interferon alpha (used to treat certain viral and tumor infections),
• lithium (used in certain psychiatric illnesses),
• cancer or rheumatoid arthritis (methotrexate),
• medications used to treat gout (probenecid),
• vancomycin (antibiotic used for infections),
• zidovudine (used in the treatment of patients infected with the human immunodeficiency virus, the cause of AIDS).

Interference with diagnostic tests

If you are going to undergo any diagnostic tests (including blood tests, urine tests, etc.), inform your doctor that you are taking this medication, as it may alter the results.

Taking Aspirin with food, drinks, and alcohol

Take this medication after meals or with some food.

If you regularly consume alcohol (three or more alcoholic beverages - beer, wine, liquor, etc. - per day), taking Aspirin may cause stomach bleeding.

Pregnancy

Consult your doctor or pharmacist before using any medication.

Breastfeeding

Consult your doctor or pharmacist before using any medication.

Women who are breastfeeding should consult their doctor before using this medication, as acetylsalicylic acid passes into breast milk.

Use in children

Do not administer to children under 16 years of age.

Use in adults over 65 years of age

Older adults should not take this medication without consulting their doctor, as they are more likely to experience side effects.

Driving and using machines

No effects on the ability to drive or use machines have been reported.

3. How to take Aspirin

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

This medication is administered orally.

Adults and adolescents over 16 years of age: 1 tablet (500 mg of acetylsalicylic acid) every 4 or 6 hours, if necessary. Do not exceed 8 tablets (4 g of acetylsalicylic acid) in 24 hours.

Patient with reduced liver or kidney function: consult your doctor, as the dose should be reduced.

Tablets should be taken with a glass of water, after meals or with some food.

Do not take this medication on an empty stomach.

Always use the lowest effective dose.

The administration of this preparation is subject to the appearance of painful or febrile symptoms. As they disappear, this medication should be discontinued.

If the pain persists for more than 5 days, or the fever for more than 3 days, or the symptoms worsen or other symptoms appear, you should interrupt treatment and consult your doctor.

If you take more Aspirin than you should

The main symptoms of overdose are: headache, dizziness, ringing in the ears, blurred vision, drowsiness, sweating, rapid breathing, mental confusion, nausea, vomiting, and occasionally diarrhea.

It is recommended to take the package and package leaflet of the medication to the healthcare professional.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or go to a medical center immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Common side effects (may affect up to 1 in 10 people):

• Gastrointestinal disorders, such as stomach ulcers, intestinal ulcers, gastrointestinal bleeding, abdominal pain, indigestion, heartburn, acidity, gastric discomfort, nausea, and vomiting.

• Respiratory disorders, such as difficulty breathing (asthma, bronchospasm), nasal congestion, and rhinitis.
• Urticaria, skin rashes, angioedema (inflammation and swelling that affects the face, lips, mouth, tongue, or throat, which can cause difficulty swallowing or breathing) and itching.
• Hypoprothrombinemia (coagulation disorder) when administered in high doses.

Uncommon side effects (may affect up to 1 in 100 people):

• Reye's Syndrome in children under 16 years of age with febrile conditions, flu, or chickenpox (see "Before taking Aspirin").

• Liver disorders, especially in patients with juvenile arthritis.
• Anemia.

With prolonged doses of acetylsalicylic acid, the following side effects have been observed, whose frequency cannot be established with precision: dizziness, ringing in the ears, deafness, sweating, headache, confusion, renal insufficiency, and acute interstitial nephritis (inflammation at the kidney level).

If you notice the appearance of:

• discomfort or stomach pain, gastrointestinal bleeding or black stools,
• skin disorders, such as rashes or redness,
• difficulty breathing,
• unforeseen changes in the amount or appearance of urine,
• swelling of the face, feet, or legs,
• deafness, ringing in the ears, or dizziness,

stop taking the medication and consult your doctor immediately, as they may indicate the appearance of side effects that require urgent medical attention.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Aspirin

Do not store above 30°C.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date shown on the package, after the abbreviation CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need in the Sigre Collection Point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Aspirin

Each tablet contains as active ingredient: acetylsalicylic acid, 500 mg. The other components (excipients) are: powdered cellulose and cornstarch.

Appearance of Aspirin and package contents

Round, white tablets with the Bayer cross anagram on one side and Aspirin 0.5 on the other.

It is presented in propylene and aluminum blisters with 10 tablets.

Packages with 10 or 20 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Bayer Hispania, S.L.

Av. Baix Llobregat, 3-5

08970 Sant Joan Despí (Barcelona)

Spain

Manufacturer

Bayer Bitterfeld GmbH

OT Greppin

Salegaster Chausee, 1

06803 Bitterfeld-Wolfen

Germany

Date of the last revision of this package leaflet:October 2023

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es